Clinical Study Documentation Pro — IRB & Compliance

Caris Life Sciences; United States; Remote; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Paid time off

401k match

Employee assistance program

Job summary

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored studies and collaborative research. You will manage study documents, coordinate IRB submissions, and engage with research sites to ensure compliance and readiness for inspections.

The role requires an associate degree and at least 2 years of IRB document submission experience, with strong regulatory knowledge and proficiency in Microsoft Office and CTMS systems.

Qualifications

• Associates degree is required.
• 2 years experience with preparing and submitting IRB documents.
• Strong understanding of clinical research documentation and regulatory processes.
• Proficient in Microsoft Office and navigating regulatory/trial management systems.
• Strong organizational skills and attention to detail in documentation and communication.
• Ability to manage multiple studies and priorities with minimal supervision.
• Pre-employment checks (background, drug screen, references).

Responsibilities

• Prepare and submit study documents to IRBs and other oversight entities.
• Maintain study files, licenses, staff certifications, training records, and equipment logs.
• Review study binders and systems to ensure documents are current and complete.
• Act as liaison between internal teams, sites, IRBs, and sponsors for timely submissions.
• Track progress in CTMS, IRB portals, and sponsor systems.
• Assist with site onboarding and study activation.
• Participate in meetings to provide status updates on documents timelines.
• Ensure compliance with GCP, HIPAA, FDA, and other guidelines.
• Assist in development and delivery of GCP training.
• Support updates to SOPs and regulatory processes.

Skills

Attention to detail

Organization

Multitasking

Regulatory knowledge

Communication

Education

Associate degree

Bachelor's degree in life sciences or related field

Tools

Microsoft Office

CTMS

IRB portals

Job description

Caris Life Sciences is seeking a Clinical Study Documentation Specialist to support Caris-sponsored studies and collaborative research. You will manage study documents, coordinate IRB submissions, and engage with research sites to ensure compliance and readiness for inspections.

The role requires an associate degree and at least 2 years of IRB document submission experience, with strong regulatory knowledge and proficiency in Microsoft Office and CTMS systems.